Rituximab Plus Bendamustine as Front Line Treatment in Frail Elderly (>70 Years) Patients With DLBCL: a Phase II Multicenter Study of the FIL

NCT01990144 | Unknown Phase 2 DMC

• 1 other identifier: FIL_R-BENDA FRAIL
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 52

Brief Summary

The purpose of the study is to evaluate feasibility and efficacy of rituximab-bendamustine (R-B)combination in elderly patients affected by diffuse large B-cell lymphoma and defined as frail according to CGA.

Conditions

Diffuse Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• To evaluate the activity of R-B combination in terms of complete response rate (CRR).

  4 years

• To evaluate the safety and tolerability of R-B combination in terms of rate of adverse events occurrence.

  4 years

Secondary Outcomes (2)

• To evaluate progression free survival (PFS)

  4 years

• To evaluate overall survival (OS)

  4 years

Study Arms (1)

Bendamustine

EXPERIMENTAL

Bendamustine is a novel chemotherapeutic agent, a hybrid of a purine analogue and an alkylator. It shows only partial in vitro cross-resistance with other alkylating agents and it is clinically well tolerated. In fact it has shown to be active in vitro against cell lines which are resistant to other alkylating agents. Preclinical data demonstrate that bendamustine acts in two distinct ways to kill cancer cells: it damages the DNA in cancer cells, which leads to cell death by a process known as apoptosis (programmed cell death) as well as by an alternate cell death pathway known as mitotic catastrophe (a disruption of normal cell division). This dual-effect may be attributable to its unique chemical structure.Bendamustine has demonstrated clinical activity in patients with chronic lymphocytic leukaemia, patients with relapsed indolent NHL, mantle cell lymphoma, multiple myeloma and several solid tumors.

Drug: Bendamustine+Rituximab

Interventions

Bendamustine+Rituximab DRUG

Patients will receive : * Rituximab 375 mg/m2 intravenously on day 1\* * Bendamustine 90 mg/m2 intravenously on days 2 and 3\*\* Treatment will be administered on a 28-day cycle basis. * Administration of rituximab during cycle 1 is postponed to day 8, thereafter on day 1. * After the first cycle, bendamustine can be administered on days 1-2 or days 2-3 according to Institutional/patient/physician choice.

Bendamustine

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Histologically proven CD20 positive diffuse large B-cell non-Hodgkin's lymphoma
• Age \> 70 years
• No previous treatment
• FRAIL patients defined as follows (see Appendices B-E) Age \> 80 years with UNFIT profile, i.e.
• ADL \> 5 residual functions
• IADL \> 6 residual functions
• CIRS 5-8 co-morbidities of grade 2
• or Age \< 80 years with
• ADL \< 4 residual functions, or
• IADL \< 5 residual functions, or
• CIRS : 1 co-morbidity of grade 3-4, or \> 8 co-morbidities of grade 2
• Life expectancy \> 6 months
• Written informed consent
• Accessibility of patient for treatment and follow up

You may not qualify if:

• History of other malignancies within 5 years prior to study entry except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer
• Previous exposure to cytotoxic agents
• Suspect or clinical evidence of CNS involvement by lymphoma
• HBsAg, HCV or HIV positivity; HBcAb positivity is accepted only with concomitant treatment with Lamivudine
• AST /ALT \> twice upper the normal range; bilirubin \> twice upper the normal range; serum creatinine \> 2.5 mg /dl
• Evidence of any severe active acute or chronic infection
• Concurrent co-morbid medical condition which might exclude administration of full dose chemotherapy
• Senile dementia
• Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent

Sponsors & Collaborators

• Fondazione Italiana Linfomi - ETS: lead

Study Sites (52)

Ospedale Civile Ss. Antonio E Biagio Di Alessandria

Alessandria, Alessandria, 15121, Italy

RECRUITING

Ente Eccl.Osp.Gen.Reg.'Miulli'

Acquaviva delle Fonti, Bari, 70124, Italy

RECRUITING

Ospedale S. Nicola Pellegrino Di Trani

Trani, Barletta, 76125, Italy

RECRUITING

Asp Di Bolzano - Comprensorio Sanitario Di Bolzano

Bolzano, Bolzano, 39100, Italy

RECRUITING

Pres.Ospedal.Spedali Civili Brescia

Brescia, Brescia, 25123, Italy

RECRUITING

Stabilimento "Perrino"

Brindisi, Brindisi, 72100, Italy

RECRUITING

Ospedale Armando Businco -

Cagliari, Cagliari, 09123, Italy

RECRUITING

A.O. Universitaria Ospedale Vittorio Emanuele E Ferrarotto Di Catania

Catania, Catania, 95124, Italy

RECRUITING

Nuovo Ospedale Garibaldi - Nesima

Catania, Catania, 95124, Italy

RECRUITING

Osp.Generale Di Zona Valduce

Como, Como, 22100, Italy

RECRUITING

Presidio Ospedaliero Annunziata

Cosenza, Cosenza, 87100, Italy

RECRUITING

Irccs Ospedale Casa Sollievo Della Sofferenza

San Giovanni Rotondo, Foggia, 71013, Italy

RECRUITING

Irst - Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori

Meldola, Forlì-Cesena, 47014, Italy

RECRUITING

A.O. Universitaria S. Martino Di Genova

Genova, Genova, 16132, Italy

RECRUITING

Ospedale Generale Di Zona

Civitanova Marche, Macerata, 62012, Italy

RECRUITING

Presidio Ospedaliero Matera

Matera, Matera, 75100, Italy

RECRUITING

A.O. Universitaria Policlinico Martino Di Messina

Messina, Messina, 98125, Italy

RECRUITING

Azienda Ospedaliera Papardo

Messina, Messina, 98158, Italy

RECRUITING

Irccs Istituto Nazionale Dei Tumori (Int)

Milan, Milano, 20133, Italy

RECRUITING

Ospedale S. Carlo Borromeo

Milan, Milano, 20153, Italy

RECRUITING

Ospedale Ca' Granda-Niguarda

Milan, Milano, 20162, Italy

RECRUITING

A.O. Universitaria Policlinico Di Modena

Modena, Modena, 41124, Italy

RECRUITING

Nuovo Ospedale Di Sassuolo S.P.A.

Sassuolo, Modena, 41049, Italy

RECRUITING

Azienda Ospedaliera S. Gerardo Di Monza

Monza, Monza, 20900, Italy

RECRUITING

Irccs Istituto Oncologico Veneto (Iov)

Padua, Padova, 35128, Italy

RECRUITING

A.O. Universitaria Policlinico Giaccone Di Palermo

Palermo, Palermo, 90127, Italy

RECRUITING

A.O. "V. Cervello"

Palermo, Palermo, 90146, Italy

RECRUITING

Casa Di Cura La Maddalena Di Palermo

Palermo, Palermo, 90146, Italy

RECRUITING

A.O. Universitaria Di Parma

Parma, Parma, 43126, Italy

RECRUITING

Ospedale Civile Spirito Santo

Pescara, Pescara, 65100, Italy

RECRUITING

Ausl Di Piacenza

Piacenza, Piacenza, 29121, Italy

RECRUITING

A.O. Universitaria Pisana

Pisa, Pisa, 56126, Italy

RECRUITING

Irccs Centro Di Riferimento Oncologico (Cro)

Aviano, Pordenone, 33081, Italy

RECRUITING

Irccs Centro Di Riferimento Oncologico Di Basilicata (Crob)

Rionero in Vulture, Potenza, 85128, Italy

RECRUITING

Ospedale S. Maria Delle Croci Di Di Ravenna

Ravenna, Ravenna, 48121, Italy

RECRUITING

Ospedale Bianchi - Melacrino - Morelli

Reggio Calabria, Reggio Calabria, 89124, Italy

RECRUITING

Ospedale Di S. Maria Nuova

Reggio Emilia, Reggio Emilia, 42100, Italy

RECRUITING

Ospedale Di Rimini

Rimini, Rimini, 47900, Italy

RECRUITING

Irccs Istituto Regina Elena (Ifo)

Roma, Roma, 00144, Italy

RECRUITING

Ospedale S. Eugenio

Roma, Roma, 00144, Italy

RECRUITING

Azienda Osp. S.Giovanni/Addolorata Roma

Roma, Roma, 00184, Italy

RECRUITING

P.O. Umberto I

Nocera Inferiore, Salerno, 84014, Italy

RECRUITING

A.O.Oo.Rr.S.Giovanni Di Dio E Ruggi D'Ar

Salerno, Salerno, 84100, Italy

RECRUITING

A.O. Universitaria Policlinico Di Sassari

Sassari, Sassari, 07100, Italy

RECRUITING

A.O. Universitaria Senese

Siena, Siena, 53100, Italy

RECRUITING

Stabilimento Ss. Annunziata

Taranto, Taranto, 74100, Italy

RECRUITING

Azienda Ospedaliera "S. Maria"

Terni, Terni, 05100, Italy

RECRUITING

Ospedale Civile Di Ivrea

Ivrea, Torino, 10015, Italy

RECRUITING

Ematologia 1 - A.O. UNIVERSITARIA S. GIOVANNI BATTISTA-MOLINETTE DI TORINO

Torino, Torino, 10126, Italy

RECRUITING

Ematologia 2 - A.O. UNIVERSITARIA S. GIOVANNI BATTISTA-MOLINETTE DI TORINO

Torino, Torino, 10126, Italy

RECRUITING

Ematologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI

Varese, Varese, 21100, Italy

RECRUITING

Oncologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI

Varese, Varese, 21100, Italy

RECRUITING

Related Publications (1)

• Storti S, Spina M, Pesce EA, Salvi F, Merli M, Ruffini A, Cabras G, Chiappella A, Angelucci E, Fabbri A, Liberati AM, Tani M, Musuraca G, Molinari A, Petrilli MP, Palladino C, Ciancia R, Ferrario A, Gasbarrino C, Monaco F, Fraticelli V, De Vellis A, Merli F, Luminari S. Rituximab plus bendamustine as front-line treatment in frail elderly (>70 years) patients with diffuse large B-cell non-Hodgkin lymphoma: a phase II multicenter study of the Fondazione Italiana Linfomi. Haematologica. 2018 Aug;103(8):1345-1350. doi: 10.3324/haematol.2017.186569. Epub 2018 May 10.

  PMID: 29748444 DERIVED

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Michele Spina, MD

  IRCCS CENTRO DI RIFERIMENTO ONCOLOGICO (CRO) - AVIANO (PN)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Calabrese, Dr

CONTACT

+39 0131 206129; segreteria@filinf.it

Sonia Perticone, Dr

CONTACT

+39 0131 206129; segreteria@filinf.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2013
• First Posted: November 21, 2013
• Study Start: November 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2016
• Last Updated: November 21, 2013

Record last verified: 2013-11

Locations

IT (52)